35 Pediatric Obstructive Sleep Apnea for Sleep Apnea, Obstructive

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA, Los Angeles, CA
Sleep Apnea, Obstructive+2 More
Adenotonsillectomy - Procedure
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

Obstructive sleep apnea (OSA) is highly prevalent in children and is often caused by overgrowth of the child's adenoids and/or tonsils. Consequently, adenotonsillectomy (removal of the tonsils and adenoids) is the most common treatment of OSA in children, although just the tonsils or adenoids may be removed depending on the case. As well, OSA in children is often associated with cognitive dysfunction and mood issues, suggesting brain changes due to the condition. However, the link between brain changes, cognitive and moods issues, and OSA in children has not been thoroughly explored. Therefore, this study aims to examine brain changes, cognition and mood in pediatric OSA subjects compared to controls as well as before and after removal of the adenoids and/or tonsils. This study hopes to enroll 70 subjects, ages 7-12 years, 35 healthy controls and 35 subjects diagnosed with OSA and scheduled for an adenoidectomy and/or tonsillectomy. Control subjects will schedule one visit to UCLA and OSA subjects will schedule two. Upon the first visit, all subjects will undergo cognitive, mood and sleep questionnaires and MRI scanning. That will be the duration of the controls' participation in the study; however, OSA subjects will return 6 months later (after their adenoidectomy and/ or tonsillectomy) to repeat the same procedures. Sleep quality, mood, cognition and brain images will be compared between OSA and controls and between OSA subjects before surgery and after surgery.

Eligible Conditions

  • Sleep Apnea, Obstructive
  • Pediatric Obstructive Sleep Apnea

Treatment Effectiveness

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: 6 months

6 months
Brain tissue changes between baseline and after adenotonsillectomy.
Cognition assessment after adenotonsillectomy in pediatric obstructive sleep apnea patients.
Cognitive symptoms examination after adenotonsillectomy surgery.
Mood changes after adenotonsillectomy surgery.
Neural response changes before and after adenotonsillectomy.
Regional brain cerebral blood flow changes between baseline and after adenotonsillectomy.

Trial Safety

Trial Design

1 Treatment Group

35 Pediatric Obstructive Sleep Apnea
1 of 1
Experimental Treatment

70 Total Participants · 1 Treatment Group

Primary Treatment: 35 Pediatric Obstructive Sleep Apnea · No Placebo Group · N/A

35 Pediatric Obstructive Sleep Apnea
Procedure
Experimental Group · 1 Intervention: Adenotonsillectomy · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adenotonsillectomy
2014
N/A
~730

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Trial Background

Prof. Rajesh Kumar, PhD
Principal Investigator
University of California, Los Angeles
Closest Location: UCLA · Los Angeles, CA
Photo of Los Angeles  1Photo of Los Angeles  2Photo of Los Angeles  3
2020First Recorded Clinical Trial
1 TrialsResearching Sleep Apnea, Obstructive
245 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are healthy.
Pediatric OSA subjects will be in the age range 7-12 years (upper and lower age limit will be chosen to avoid developmental-related brain changes and potential requirement of anesthesia for brain MRI).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References